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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215859

XARELTO (RIVAROXABAN)
1MG/ML
Marketing Status: Prescription
Active Ingredient: RIVAROXABAN
Proprietary Name: XARELTO
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 1MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215859
Product Number: 001
Approval Date: Dec 20, 2021
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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